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Anti-metabolites
5-Azacitidine + Decitabine for Myelodysplastic Syndrome
Phase < 1
Recruiting
Led By Benjamin H Tomlinson, Tomlinson
Research Sponsored by Benjamin Tomlinson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have MDS or MDS/myeloproliferative overlap disorder with potential sensitivity to HMA therapy, defined as prior published evidence of response to HMA
Participants must have performance status of 60% or greater by Karnofsky Performance Status (KPS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 12 weeks, 24 weeks and up to 2 years from end of treatment
Awards & highlights
Study Summary
This trial is studying how well 5-azacitidine and decitabine work when given together in treating patients with myelodysplastic syndrome.
Who is the study for?
This trial is for individuals with myelodysplastic syndrome or related disorders who may benefit from HMA therapy. They must be in a condition to perform daily activities at least 60% of their capacity and have organs functioning well enough to handle the treatment. Participants need to understand and consent to the study, but can't join if they've had certain high-risk MDS, previous similar treatments, other ongoing conditions that could affect safety, are pregnant/breastfeeding, unwilling to use contraception or have unresolved severe side effects from past therapies.Check my eligibility
What is being tested?
The trial tests alternating low doses of two FDA-approved chemotherapy drugs, 5-azacytidine (5AZA) and decitabine (DEC), for treating bone marrow failure syndromes like myelodysplastic syndrome. The goal is to see if this approach can overcome resistance seen when these drugs are used alone by affecting DNA metabolism in abnormal cells.See study design
What are the potential side effects?
Potential side effects include damage not only to abnormal cells but also normal ones due to the nature of chemotherapy which affects cell DNA. This might lead to fatigue, nausea, infections due to lowered white blood cell counts, bleeding issues from reduced platelets and anemia caused by fewer red blood cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have MDS or MDS/myeloproliferative disorder and may respond to HMA therapy.
Select...
I am mostly independent and can care for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, 12 weeks, 24 weeks and up to 2 years from end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 12 weeks, 24 weeks and up to 2 years from end of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR) of 5AZA-alt-DEC
Secondary outcome measures
Cumulative incidence of response for both CR and overall response
Duration of response (DOR)
Safety evaluation by tabulation of all AEs and SAEs per CTACE version 5.0
Other outcome measures
Correlation of clinical response IWG criteria with disease biological phenotype
Correlation of predicted DNMT1 depletion with clinically assessed DNMT1 depletion as evaluated by flow cytometry
Correlation of predicted DNMT1 depletion with clinically assessed DNMT1 depletion as evaluated by quantitative immunofluorescence
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: 5AZA-alt-DECExperimental Treatment2 Interventions
Participants will be treated for a minimum of 24 weeks in the absence of clear evidence of progressive disease. Patients who have any response will be permitted to continue treatment until relapse or progression of disease that is not sensitive to protocol defined dose escalation.
Treatments will include:
5-azacytidine (50mg/m^2) Day 1 every week
Decitabine (5mg/m^2) Day 4 every week
Weeks 1-8 will be an induction phase, and weeks 9+ will be a long-term treatment phase
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved
Decitabine
FDA approved
Find a Location
Who is running the clinical trial?
Benjamin TomlinsonLead Sponsor
3 Previous Clinical Trials
87 Total Patients Enrolled
Benjamin H Tomlinson, TomlinsonPrincipal InvestigatorCleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Any severe side effects from my previous cancer treatments have improved.You have any other medical condition that could make it unsafe for you to participate in the study or could make it difficult to accurately evaluate the study results.My organs are functioning well.I have MDS or MDS/myeloproliferative disorder and may respond to HMA therapy.My MDS is classified as high risk or very high risk.I haven't taken any cancer treatment except hydroxyurea in the last 14 days.I am not willing to use two forms of birth control.I am mostly independent and can care for myself.You have a mental health condition or social situation that might make it difficult for you to follow the study rules.I have previously been treated with azacitidine, decitabine, or similar drugs.I am a sexually active male unwilling to use condoms with women who can get pregnant.I am allergic to components in azacitidine or decitabine treatments.I have an active HIV infection.
Research Study Groups:
This trial has the following groups:- Group 1: 5AZA-alt-DEC
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What ailments does 5-azacytidine typically provide relief for?
"5-azacytidine is often utilized for induction chemotherapy, but it also has other medical applications such as risk category intermediate-2 ipsilateral cases, refractory anemias, acute myelocytic leukemia."
Answered by AI
What is the cap on enrollees for this research project?
"Affirmative. According to clinicaltrials.gov, this medical trial commenced on November 16th 2020 and is currently looking for volunteers. Only 20 participants are required at one site."
Answered by AI
Is enrollment still taking place for this research endeavor?
"Indeed, the data hosted on clinicaltrials.gov reveals that this medical trial is actively accepting participants. The study was first announced on November 16th 2020 and its latest update was obtained in August 10th 2022."
Answered by AI
Are there other recorded experiences of 5-azacytidine being studied in a research setting?
"Presently, 262 trials are underway exploring the potential of 5-azacytidine. Of those active studies, 46 have reached Phase 3. While Reggio Emilia and Foggia host many experiments related to this treatment, 6550 medical centres globally are conducting research for it."
Answered by AI
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